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GUEST CONTRIBUTORS

  • Supplier Selection In The Time Of Brexit: How To Get It Right
    Supplier Selection In The Time Of Brexit: How To Get It Right

    The ongoing Brexit negotiations between the British Parliament and the EU has left pharma supply chain managers scrambling for cover. As recently as October 2018, the probability of a no-deal scenario was low and it made little sense to invest in or commit to alternate plans, but this changed when Parliament rejected Prime Minister Theresa May's deal in December. The politics are not as important to business as the conclusion: The best way to mitigate disruption is to more heavily weigh finding alternate ex-U.K. suppliers versus waiting it out. Negotiating deals and supply agreements takes time, as does the logistics of tech transfer and moving materials. So risk management, timing, and terms are key success factors.

  • For Whom Is Bioprocessing Capacity Scarce?
    For Whom Is Bioprocessing Capacity Scarce?

    ISR data, collected for the purpose of improving our understanding of the much-anticipated bioprocessing capacity crunch, reveals that it is not a matter of if or when a capacity crunch will impact the biopharmaceutical industry; instead, it’s a question of who, or which types of drug innovators, will be impacted.

  • How To Write An Effective Validation Master Plan
    How To Write An Effective Validation Master Plan

    A validation master plan (VMP) outlines the principles involved in the qualification of a facility, defining the areas and systems to be validated, and provides a written program for achieving and maintaining a qualified facility. Master plans are written to assist an organization with validation strategies or to provide control over a specific process.

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PHARMA OUTSOURCING WHITE PAPERS

Cell Therapy Logisitics Cell Therapy Logisitics

Having a sound logistics strategy is critical to ensuring this living drug is delivered to the right patient at the right time, location, and temperature is essential to patient safety and product effectiveness.This paper will walk through key considerations for developing a successful logistics strategy for the management of cell-based material.

Avoiding Hemolysis Blood Sample Collection Processing Avoiding Hemolysis Blood Sample Collection Processing

Hemolysis is a primary driver of the need for re-draw, resulting in wasted time and resources. This paper explains how can hemolysis be prevented during specimen collection as well as hemolysis and specimen handling.

Towards A Unified Process Development Strategy For Batch And Continuous Chromatography

Here we describe a process development methodology that enables design of either a batch or a continuous chromatography step based on the same set of experimental data.

Overview Of A Scale-Up Of A Cell-Based Influenza Virus Production Process Using Single-Use Bioprocessing Equipment

This paper includes a discussion on vaccine processes, followed by a case study on the scale-up of upstream and downstream processes for the production of a cell-based live attenuated influenza virus using single-use ReadyToProcess technology.

Unlocking The Potential For Efficiency In Downstream Bioprocesses

In the bioprocessing industry, in order to make full use of upstream advances in an efficient manner, it is essential that downstream processes are intensified.

Defense In Depth: Off-Site Storage Of Biological Specimens And Biopharmaceuticals For Risk Mitigation

Choosing an offsite storage facility means asking the right questions, to determine if the storage provider has the appropriate risk mitigation infra-structure in place, beginning with a realistic threat assessment for the location.

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PHARMA OUTSOURCING APP NOTES & CASE STUDIES

Outsourcing Insights
If you have been in the pharmaceutical industry for an extended period of time, you’ve likely noticed how CROs have evolved from offering basic support to providing a wide range of clinical, central laboratory, and analytical services to meet market demands. By Victor Coker, director of business intelligence, Nice Insight
This Is NOT Your Sponsor’s CTMS

Sponsors do have their own CTMS or EDC systems and sites log into them to enter clinical data for a given sponsor or trial. But none of these systems belong to the site and none are devoted to the business operations of the site across all studies.

Continuous Processing Optimization With Smarter Tools

Due to a paradigm shift in the pharmaceutical industry, there is rising pressure to come up with faster, more cost-effective ways to produce drugs for the patients who need them.

Single-Use Technology And Sustainability: GE Quantifies The Environmental Impact

In the shift to single-use technology, there is both an opportunity and an obligation to understand the sustainability impacts of this development.

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